A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/26/2018 |
| Start Date: | November 5, 2014 |
| End Date: | January 12, 2015 |
Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects
This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male
and female subjects. There is no formal hypothesis, however, it is expected that the
coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase
the systemic exposure of BMS-626529.
and female subjects. There is no formal hypothesis, however, it is expected that the
coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase
the systemic exposure of BMS-626529.
Inclusion Criteria:
- Healthy male and female
- Nonsmoking subjects
- Ages 18 to 50 years
- Inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
- Women of childbearing potential
- Must agree to follow instructions for methods of contraception for the duration of the
study plus 34 days post-treatment completion
Exclusion Criteria:
- Any history of acute or chronic medical and surgical illness.
- Personal of family history of hemophilia A or B
- Other protocol defined exclusion criteria could apply
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